Effect of Rocuronium on BIS Values

Completed

• Conditions: Breast Cancer; General Anaesthesia

• Registration Number: NCT05681611
• Lead Sponsor: University of Padova

Brief Summary

Aim of this trial is to define if Trend of Four (TOF) values after a bolus of rocuronium is correlated with Bispectral Index BIS values during standard general anaesthesia for breast surgery.

Detailed Description

Rocuronium. a curarizing agent, has been shown to decrease Bispectral Index (BIS) in awake volunteers.

However, correlation between Trend of Four (TOF) values after a bolus of rocuronium and BIS values during general anaesthesia for breast surgery has not been defined yet.

Investigators want to analyze this correlation during general anaesthesia conducted using Propofol and remifentanil. All of these drugs will be delivered with Targeted-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil), commonly used to deliver general anaesthesia. At stable anaesthesia maintenance, if requested for surgical (ie more muscle relaxation) or anesthesiological reasons (i.e. avoid air insufflation) a standard Rocuronium bolus (0.6 mg/kg) was given. In these case, with rocuronium bolus justified by clinical reasons, authors will observationally record the BIS values and the TOF values.

Study Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-12
• Study Start: 2023-03-03
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

• Undergo General Anaesthesia with Propofol and Remifentanil, and necessity of curarization with Rocuronium for surgical or ventilatory reasons.

Exclusion Criteria

• Neurological disease
• Psychiatric disease
• Benzodiazepines praemedication
• Obesity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between Trend of Four (TOF) and Bispectral Index (BIS) values	60 minutes after rocuronium bolus	Discover if there is linear correlation between TOF values (utilized for curarization monitoring) and BIS values (utilized for deep of hypnosis monitoring) during standard general anaesthesia conducted with Propofol and remifentanil with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia

Trial Locations

Locations (1)

ULSS2; 🇮🇹 Treviso, Italy